Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer

NCT ID: NCT00492778

Last Updated: 2023-03-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-25

Brief Summary

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This randomized phase II trial studies radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with endometrial cancer that has come back. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer.

Detailed Description

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PRIMARY OBJECTIVES:

I. To assess whether pelvic radiation therapy with concurrent cisplatin is more promising with respect to progression-free survival than pelvic radiation therapy alone in the treatment of recurrent uterine carcinoma limited to the pelvis and vagina.

SECONDARY OBJECTIVES:

I. To capture the sites of recurrence subsequent to treatment with pelvic radiation with or without concurrent weekly cisplatin in women with recurrent uterine carcinoma.

II. To estimate overall survival of patients with recurrent uterine carcinoma treated with pelvic radiation therapy with or without concurrent weekly cisplatin.

III. To estimate the prognostic significance of the location (central pelvis versus vagina) and size of the recurrence, in addition to the prognostic significance in the salvage setting of the histological subtype, grade, patient age, race, performance status, and the presence of lymph-vascular space involvement of the original tumor at the time of initial hysterectomy.

IV. To evaluate toxicity derived from the combined cisplatin and radiation compared with radiation alone in this patient population.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo external-beam radiotherapy (EBRT) to the pelvis daily on days 1-5 for 5 weeks. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy\* or low-dose rate interstitial brachytherapy\*.

ARM II: Patients undergo EBRT as in Arm I and receive cisplatin intravenously (IV) over 1-2 hours on days 1, 8, 15, 22, and 29. Patients then undergo brachytherapy\* as in Arm I.

NOTE: \*IMRT boost is allowed for patients who are not candidates for brachytherapy. IMRT may also be used for the entire course of therapy for the treatment of the whole pelvis and/or the boost in patients not undergoing brachytherapy. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every month for 3 months, 3 months for 2 years and then every 6 months for 3 years.

Conditions

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Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation Endometrial Mucinous Adenocarcinoma Endometrial Squamous Cell Carcinoma Recurrent Endometrial Clear Cell Adenocarcinoma Recurrent Endometrial Endometrioid Adenocarcinoma Recurrent Endometrial Serous Adenocarcinoma Recurrent Endometrial Undifferentiated Carcinoma Recurrent Uterine Corpus Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (brachytherapy, radiation therapy)

Patients undergo EBRT to the pelvis daily on days 1-5 for 5 weeks. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy or low-dose rate interstitial brachytherapy.

Group Type EXPERIMENTAL

3-Dimensional Conformal Radiation Therapy

Intervention Type RADIATION

Undergo 3-dimensional conformal radiation therapy

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Internal Radiation Therapy

Intervention Type RADIATION

Given intracavitarily or interstitially

Arm II (brachytherapy, radiation therapy, cisplatin)

Patients undergo EBRT as in Arm I and receive cisplatin IV over 1-2 hours on days 1, 8, 15, 22, and 29. Patients then undergo brachytherapy as in Arm I.

Group Type EXPERIMENTAL

3-Dimensional Conformal Radiation Therapy

Intervention Type RADIATION

Undergo 3-dimensional conformal radiation therapy

Cisplatin

Intervention Type DRUG

Given IV

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Internal Radiation Therapy

Intervention Type RADIATION

Given intracavitarily or interstitially

Interventions

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3-Dimensional Conformal Radiation Therapy

Undergo 3-dimensional conformal radiation therapy

Intervention Type RADIATION

Cisplatin

Given IV

Intervention Type DRUG

Intensity-Modulated Radiation Therapy

Undergo IMRT

Intervention Type RADIATION

Internal Radiation Therapy

Given intracavitarily or interstitially

Intervention Type RADIATION

Other Intervention Names

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3-dimensional radiation therapy 3D Conformal 3D CONFORMAL RADIATION THERAPY 3D CRT 3D-CRT Conformal Therapy Radiation Conformal Therapy Radiation, 3D Conformal Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone''s Chloride Peyrone''s Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin IMRT Intensity Modulated RT Intensity-Modulated Radiotherapy Radiation, Intensity-Modulated Radiotherapy Brachytherapy Brachytherapy, NOS Internal Radiation Internal Radiation Brachytherapy Radiation Brachytherapy Radiation, Internal

Eligibility Criteria

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Inclusion Criteria

* All patients must have undergone complete hysterectomy and bilateral salpingo-oophorectomy at the time of original therapy for their uterine carcinoma
* Patients must have a biopsy with histologically confirmed diagnosis of recurrent endometrial cancer confined to the pelvis and/or vagina and no evidence of extrapelvic disease
* Patients must have endometrial carcinoma including endometrioid adenocarcinoma, adenocarcinoma with squamous differentiation, mucinous adenocarcinoma, squamous cell carcinoma, mixed carcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, and serous adenocarcinoma histologies
* Patients must have no evidence of extrapelvic disease; complete workup staging should be performed prior to initiation of therapy to rule-out presence of metastatic disease; this should include: computed tomography (CT) scan of the thorax with IV contrast, as well as a CT of the pelvis and abdomen with IV and oral (PO) contrast performed using multi-detector CT and equal or less than 5 mm slice thickness; if the patient is unable to tolerate contrast, then magnetic resonance imaging (MRI) with IV gadolinium should be performed; a chest x-ray should be done first, and if abnormal, then a CT scan of the chest should be done
* Primary surgical debulking before protocol therapy is permissible; this would include removal of gross symptomatic disease in the pelvis and/or vagina

* Exenterative surgery is not permissible; patients with complete resection of gross recurrent disease are eligible
* Patients may have received prior hormone therapy and/or systemic chemotherapy; such therapy must have been completed at least 6 months prior to study entry and the patient has clear evidence of disease subsequent to such therapy; patients must not have received neoadjuvant chemotherapy for the present recurrent disease
* Patients must have Gynecologic Oncology Group (GOG) performance status 0, 1, or 2
* Patients must have an estimated survival greater or equal to 3 months
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3 , equivalent to Common Toxicity Criteria (Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 3.0) grade 1
* Platelets \>= 100,000/mm\^3 (CTCAE v 3.0 grade 0-1)
* Creatinine =\< institutional upper limit normal (ULN), CTCAE v 3.0 grade 0; NOTE: if creatinine \> ULN, creatinine clearance must be \> 50 mL/min
* Bilirubin =\< 1.5 x ULN (CTCAE v 3.0 grade 1)
* Serum glutamic oxaloacetic transaminase (SGOT) =\< 2.5 x ULN (CTCAE v 3.0 grade 0-1)
* Alkaline phosphatase =\< 2.5 x ULN (CTCAE v 3.0 grade 0-1)
* Neuropathy (sensory and motor) =\< CTCAE v 3.0 grade 1
* Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
* Patients who have met the pre-entry requirements
* Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria

* Patients with evidence of disease outside of the pelvis, including presence of positive periaortic or inguino-femoral nodes
* Patients who have received previous vaginal, pelvic, or abdominal irradiation
* Patients who received chemotherapy directed at the present recurrence
* Patients with septicemia or severe infection
* Patients who have circumstances that will not permit completion of this study or the required follow-up
* Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields
* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
* Patients who have undergone complete surgical resection of the recurrent tumor and have no evidence of residual disease evaluable clinically and by CT or MRI imaging, following resection
* Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias within 6 months of registration
* Patients with history of active collagen vascular disease
* Patients with GOG performance grade of 3 or 4
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

GOG Foundation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan M Feddock

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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Sutter Auburn Faith Hospital

Auburn, California, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

Site Status

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Site Status

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status

Mills-Peninsula Medical Center

Burlingame, California, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Site Status

Eden Hospital Medical Center

Castro Valley, California, United States

Site Status

Sutter Davis Hospital

Davis, California, United States

Site Status

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Memorial Medical Center

Modesto, California, United States

Site Status

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Site Status

Palo Alto Medical Foundation-Gynecologic Oncology

Mountain View, California, United States

Site Status

Sutter Cancer Research Consortium

Novato, California, United States

Site Status

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Site Status

Sutter Roseville Medical Center

Roseville, California, United States

Site Status

Sutter Medical Center Sacramento

Sacramento, California, United States

Site Status

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

University of California San Diego

San Diego, California, United States

Site Status

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Site Status

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, United States

Site Status

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Site Status

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Site Status

Olive View-University of California Los Angeles Medical Center

Sylmar, California, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Vacaville, California, United States

Site Status

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Site Status

University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Site Status

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Site Status

Beebe Medical Center

Lewes, Delaware, United States

Site Status

Christiana Gynecologic Oncology LLC

Newark, Delaware, United States

Site Status

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Site Status

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status

TidalHealth Nanticoke / Allen Cancer Center

Seaford, Delaware, United States

Site Status

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Site Status

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Site Status

Sarasota Memorial Hospital

Sarasota, Florida, United States

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Northside Hospital

Atlanta, Georgia, United States

Site Status

Augusta University Medical Center

Augusta, Georgia, United States

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Northeast Georgia Medical Center-Gainesville

Gainesville, Georgia, United States

Site Status

Memorial Health University Medical Center

Savannah, Georgia, United States

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Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Site Status

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

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Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Site Status

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

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Walter Knox Memorial Hospital

Emmett, Idaho, United States

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Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Site Status

Saint Alphonsus Medical Center-Nampa

Nampa, Idaho, United States

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Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

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Kootenai Cancer Clinic

Sandpoint, Idaho, United States

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Rush - Copley Medical Center

Aurora, Illinois, United States

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Saint Joseph Medical Center

Bloomington, Illinois, United States

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Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

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Illinois CancerCare-Canton

Canton, Illinois, United States

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Illinois CancerCare-Carthage

Carthage, Illinois, United States

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Northwestern University

Chicago, Illinois, United States

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Rush University Medical Center

Chicago, Illinois, United States

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University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

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Illinois CancerCare-Eureka

Eureka, Illinois, United States

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NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

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Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

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Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Site Status

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Site Status

Sudarshan K Sharma MD Limited-Gynecologic Oncology

Hinsdale, Illinois, United States

Site Status

Duly Health and Care Joliet

Joliet, Illinois, United States

Site Status

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Garneau, Stewart C MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Spector, David MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Trinity Medical Center

Moline, Illinois, United States

Site Status

Illinois CancerCare-Monmouth

Monmouth, Illinois, United States

Site Status

Bromenn Regional Medical Center

Normal, Illinois, United States

Site Status

Carle Cancer Institute Normal

Normal, Illinois, United States

Site Status

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

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Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Site Status

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Pekin, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, United States

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Methodist Medical Center of Illinois

Peoria, Illinois, United States

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OSF Saint Francis Medical Center

Peoria, Illinois, United States

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Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status

Valley Radiation Oncology

Peru, Illinois, United States

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Illinois CancerCare-Princeton

Princeton, Illinois, United States

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Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Site Status

Parkview Hospital Randallia

Fort Wayne, Indiana, United States

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Parkview Regional Medical Center

Fort Wayne, Indiana, United States

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Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

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Franciscan Saint Anthony Health-Michigan City

Michigan City, Indiana, United States

Site Status

Memorial Regional Cancer Center Day Road

Mishawaka, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Constantinou, Costas L MD (UIA Investigator)

Bettendorf, Iowa, United States

Site Status

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Site Status

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Site Status

Iowa Methodist Medical Center

Des Moines, Iowa, United States

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Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-Laurel

Des Moines, Iowa, United States

Site Status

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status

Siouxland Regional Cancer Center

Sioux City, Iowa, United States

Site Status

Mercy Medical Center-Sioux City

Sioux City, Iowa, United States

Site Status

Saint Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Methodist West Hospital

West Des Moines, Iowa, United States

Site Status

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

Site Status

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Site Status

Central Care Cancer Center - Garden City

Garden City, Kansas, United States

Site Status

Central Care Cancer Center - Great Bend

Great Bend, Kansas, United States

Site Status

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

Providence Medical Center

Kansas City, Kansas, United States

Site Status

Cancer Center of Kansas-Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Kansas Institute of Medicine Cancer and Blood Center

Lenexa, Kansas, United States

Site Status

Minimally Invasive Surgery Hospital

Lenexa, Kansas, United States

Site Status

Cancer Center of Kansas-Liberal

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas-Manhattan

Manhattan, Kansas, United States

Site Status

Cancer Center of Kansas - McPherson

McPherson, Kansas, United States

Site Status

Cancer Center of Kansas - Newton

Newton, Kansas, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Saint Luke's South Hospital

Overland Park, Kansas, United States

Site Status

Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Site Status

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Site Status

Associates In Womens Health

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Site Status

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Site Status

Wesley Medical Center

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

Site Status

Saint Elizabeth Medical Center South

Edgewood, Kentucky, United States

Site Status

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status

Woman's Hospital

Baton Rouge, Louisiana, United States

Site Status

Maine Medical Center-Bramhall Campus

Portland, Maine, United States

Site Status

Maine Medical Center- Scarborough Campus

Scarborough, Maine, United States

Site Status

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Site Status

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status

Christiana Care - Union Hospital

Elkton, Maryland, United States

Site Status

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Site Status

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status

UMass Memorial Medical Center - Memorial Division

Worcester, Massachusetts, United States

Site Status

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, United States

Site Status

Bixby Medical Center

Adrian, Michigan, United States

Site Status

Hickman Cancer Center

Adrian, Michigan, United States

Site Status

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

McLaren Cancer Institute-Bay City

Bay City, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Brighton

Brighton, Michigan, United States

Site Status

Saint Joseph Mercy Brighton

Brighton, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Canton

Canton, Michigan, United States

Site Status

Saint Joseph Mercy Canton

Canton, Michigan, United States

Site Status

Caro Cancer Center

Caro, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Chelsea

Chelsea, Michigan, United States

Site Status

Saint Joseph Mercy Chelsea

Chelsea, Michigan, United States

Site Status

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, United States

Site Status

Newland Medical Associates-Clarkston

Clarkston, Michigan, United States

Site Status

Beaumont Hospital - Dearborn

Dearborn, Michigan, United States

Site Status

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Ascension Saint John Hospital

Detroit, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Doctors Park

East China Township, Michigan, United States

Site Status

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Site Status

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, United States

Site Status

Genesee Hematology Oncology PC

Flint, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, United States

Site Status

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Site Status

Singh and Arora Hematology Oncology PC

Flint, Michigan, United States

Site Status

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Site Status

Academic Hematology Oncology Specialists

Grosse Pointe Woods, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, United States

Site Status

Michigan Breast Specialists-Grosse Pointe Woods

Grosse Pointe Woods, Michigan, United States

Site Status

Allegiance Health

Jackson, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status

Sparrow Hospital

Lansing, Michigan, United States

Site Status

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

Site Status

Hope Cancer Clinic

Livonia, Michigan, United States

Site Status

Saint Mary Mercy Hospital

Livonia, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Macomb Medical Campus

Macomb, Michigan, United States

Site Status

Michigan Breast Specialists-Macomb Township

Macomb, Michigan, United States

Site Status

Saint Mary's Oncology/Hematology Associates of Marlette

Marlette, Michigan, United States

Site Status

Toledo Clinic Cancer Centers-Monroe

Monroe, Michigan, United States

Site Status

21st Century Oncology-Pontiac

Pontiac, Michigan, United States

Site Status

Hope Cancer Center

Pontiac, Michigan, United States

Site Status

Newland Medical Associates-Pontiac

Pontiac, Michigan, United States

Site Status

Saint Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

Lake Huron Medical Center

Port Huron, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Rochester Hills

Rochester Hills, Michigan, United States

Site Status

Ascension Saint Mary's Hospital

Saginaw, Michigan, United States

Site Status

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Site Status

Bhadresh Nayak MD PC-Sterling Heights

Sterling Heights, Michigan, United States

Site Status

Advanced Breast Care Center PLLC

Warren, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Macomb Professional Building

Warren, Michigan, United States

Site Status

Macomb Hematology Oncology PC

Warren, Michigan, United States

Site Status

Michigan Breast Specialists-Warren

Warren, Michigan, United States

Site Status

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Site Status

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, United States

Site Status

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Site Status

IHA Hematology Oncology Consultants-Ann Arbor

Ypsilanti, Michigan, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status

Unity Hospital

Fridley, Minnesota, United States

Site Status

Hutchinson Area Health Care

Hutchinson, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Site Status

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Health Partners Inc

Minneapolis, Minnesota, United States

Site Status

New Ulm Medical Center

New Ulm, Minnesota, United States

Site Status

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Site Status

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

United Hospital

Saint Paul, Minnesota, United States

Site Status

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Site Status

Lakeview Hospital

Stillwater, Minnesota, United States

Site Status

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Singing River Hospital

Pascagoula, Mississippi, United States

Site Status

Central Care Cancer Center - Bolivar

Bolivar, Missouri, United States

Site Status

University of Missouri - Ellis Fischel

Columbia, Missouri, United States

Site Status

Centerpoint Medical Center LLC

Independence, Missouri, United States

Site Status

Freeman Health System

Joplin, Missouri, United States

Site Status

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Site Status

Heartland Hematology and Oncology Associates Incorporated

Kansas City, Missouri, United States

Site Status

Research Medical Center

Kansas City, Missouri, United States

Site Status

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, United States

Site Status

Liberty Radiation Oncology Center

Liberty, Missouri, United States

Site Status

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

Saint Joseph Oncology Inc

Saint Joseph, Missouri, United States

Site Status

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status

CoxHealth South Hospital

Springfield, Missouri, United States

Site Status

Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status

Saint Vincent Healthcare

Billings, Montana, United States

Site Status

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Site Status

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Site Status

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

Great Falls Clinic

Great Falls, Montana, United States

Site Status

Saint Peter's Community Hospital

Helena, Montana, United States

Site Status

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

Site Status

Community Medical Hospital

Missoula, Montana, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Cancer and Blood Specialists-Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

Site Status

Las Vegas Cancer Center-Henderson

Henderson, Nevada, United States

Site Status

21st Century Oncology-Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

Site Status

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Site Status

Cancer and Blood Specialists-Shadow

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, United States

Site Status

21st Century Oncology

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-San Martin

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, United States

Site Status

Cancer Therapy and Integrative Medicine

Las Vegas, Nevada, United States

Site Status

21st Century Oncology-Vegas Tenaya

Las Vegas, Nevada, United States

Site Status

Cancer and Blood Specialists-Tenaya

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, United States

Site Status

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada, United States

Site Status

21st Century Oncology-Fort Apache

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, United States

Site Status

Women's Cancer Center of Nevada

Las Vegas, Nevada, United States

Site Status

Wentworth-Douglass Hospital

Dover, New Hampshire, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Elliot Hospital

Manchester, New Hampshire, United States

Site Status

Cooper Hospital University Medical Center

Camden, New Jersey, United States

Site Status

Virtua Memorial

Mount Holly, New Jersey, United States

Site Status

Jersey Shore Medical Center

Neptune City, New Jersey, United States

Site Status

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Site Status

The Valley Hospital-Luckow Pavilion

Paramus, New Jersey, United States

Site Status

Valley Hospital

Ridgewood, New Jersey, United States

Site Status

Community Medical Center

Toms River, New Jersey, United States

Site Status

MD Anderson Cancer Center at Cooper-Voorhees

Voorhees Township, New Jersey, United States

Site Status

Virtua Voorhees

Voorhees Township, New Jersey, United States

Site Status

Valley Health System-Hematology/Oncology

Westwood, New Jersey, United States

Site Status

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

Southwest Gynecologic Oncology Associates Inc

Albuquerque, New Mexico, United States

Site Status

State University of New York Downstate Medical Center

Brooklyn, New York, United States

Site Status

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

Highland Hospital

Rochester, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

Site Status

Wayne Memorial Hospital

Goldsboro, North Carolina, United States

Site Status

Novant Health Presbyterian Medical Center Huntersville

Huntersville, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Summa Health System - Akron Campus

Akron, Ohio, United States

Site Status

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States

Site Status

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Site Status

Aultman Health Foundation

Canton, Ohio, United States

Site Status

Miami Valley Hospital South

Centerville, Ohio, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Site Status

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, United States

Site Status

Bethesda North Hospital

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Mount Carmel East Hospital

Columbus, Ohio, United States

Site Status

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Grant Medical Center

Columbus, Ohio, United States

Site Status

The Mark H Zangmeister Center

Columbus, Ohio, United States

Site Status

Mount Carmel Health Center West

Columbus, Ohio, United States

Site Status

Doctors Hospital

Columbus, Ohio, United States

Site Status

Grandview Hospital

Dayton, Ohio, United States

Site Status

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, United States

Site Status

Delaware Radiation Oncology

Delaware, Ohio, United States

Site Status

Grady Memorial Hospital

Delaware, Ohio, United States

Site Status

Dublin Methodist Hospital

Dublin, Ohio, United States

Site Status

Mount Carmel Grove City Hospital

Grove City, Ohio, United States

Site Status

Kettering Medical Center

Kettering, Ohio, United States

Site Status

Fairfield Medical Center

Lancaster, Ohio, United States

Site Status

Lancaster Radiation Oncology

Lancaster, Ohio, United States

Site Status

OhioHealth Mansfield Hospital

Mansfield, Ohio, United States

Site Status

Marietta Memorial Hospital

Marietta, Ohio, United States

Site Status

OhioHealth Marion General Hospital

Marion, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Maumee

Maumee, Ohio, United States

Site Status

Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

Maumee, Ohio, United States

Site Status

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

Site Status

UH Seidman Cancer Center at Landerbrook Health Center

Mayfield Heights, Ohio, United States

Site Status

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

Site Status

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status

Licking Memorial Hospital

Newark, Ohio, United States

Site Status

Newark Radiation Oncology

Newark, Ohio, United States

Site Status

Saint Charles Hospital

Oregon, Ohio, United States

Site Status

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Site Status

Springfield Regional Medical Center

Springfield, Ohio, United States

Site Status

ProMedica Flower Hospital

Sylvania, Ohio, United States

Site Status

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, United States

Site Status

University of Toledo

Toledo, Ohio, United States

Site Status

Toledo Community Hospital Oncology Program CCOP

Toledo, Ohio, United States

Site Status

Mercy Health - Saint Anne Hospital

Toledo, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, United States

Site Status

University Hospitals Sharon Health Center

Wadsworth, Ohio, United States

Site Status

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

Site Status

Saint Ann's Hospital

Westerville, Ohio, United States

Site Status

UHHS-Westlake Medical Center

Westlake, Ohio, United States

Site Status

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, United States

Site Status

Saint Alphonsus Medical Center-Baker City

Baker City, Oregon, United States

Site Status

Legacy Mount Hood Medical Center

Gresham, Oregon, United States

Site Status

Saint Alphonsus Medical Center-Ontario

Ontario, Oregon, United States

Site Status

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

Legacy Meridian Park Hospital

Tualatin, Oregon, United States

Site Status

Jefferson Abington Hospital

Abington, Pennsylvania, United States

Site Status

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Site Status

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, United States

Site Status

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Site Status

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, United States

Site Status

Pocono Medical Center

East Stroudsburg, Pennsylvania, United States

Site Status

Adams Cancer Center

Gettysburg, Pennsylvania, United States

Site Status

Cherry Tree Cancer Center

Hanover, Pennsylvania, United States

Site Status

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, United States

Site Status

Lewistown Hospital

Lewistown, Pennsylvania, United States

Site Status

Paoli Memorial Hospital

Paoli, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Reading Hospital

West Reading, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Site Status

WellSpan Health-York Cancer Center

York, Pennsylvania, United States

Site Status

WellSpan Health-York Hospital

York, Pennsylvania, United States

Site Status

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Easley

Easley, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Site Status

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Site Status

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status

Chattanooga Gynecological Oncology

Chattanooga, Tennessee, United States

Site Status

University of Tennessee - Knoxville

Knoxville, Tennessee, United States

Site Status

Parkland Memorial Hospital

Dallas, Texas, United States

Site Status

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Memorial Hermann Texas Medical Center

Houston, Texas, United States

Site Status

Methodist Willowbrook Hospital

Houston, Texas, United States

Site Status

Houston Methodist Sugar Land Hospital

Sugar Land, Texas, United States

Site Status

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status

South Jordan Health Center

South Jordan, Utah, United States

Site Status

University of Vermont Medical Center

Burlington, Vermont, United States

Site Status

University of Vermont and State Agricultural College

Burlington, Vermont, United States

Site Status

Legacy Salmon Creek Hospital

Vancouver, Washington, United States

Site Status

West Virginia University Healthcare

Morgantown, West Virginia, United States

Site Status

Green Bay Oncology at Saint Vincent Hospital

Green Bay, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Site Status

Green Bay Oncology Limited at Saint Mary's Hospital

Green Bay, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Site Status

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Site Status

Aurora West Allis Medical Center

West Allis, Wisconsin, United States

Site Status

Rocky Mountain Oncology

Casper, Wyoming, United States

Site Status

Big Horn Basin Cancer Center

Cody, Wyoming, United States

Site Status

Billings Clinic-Cody

Cody, Wyoming, United States

Site Status

Welch Cancer Center

Sheridan, Wyoming, United States

Site Status

CHUM - Hopital Notre-Dame

Montreal, Quebec, Canada

Site Status

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NCI-2009-00603

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000550975

Identifier Type: -

Identifier Source: secondary_id

GOG-0238

Identifier Type: -

Identifier Source: secondary_id

GOG-0238

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0238

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-0238

Identifier Type: -

Identifier Source: org_study_id

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